Method To Measure Protein Digestion & Absorption

Not Applicable

Completed

• Conditions: Pulmonary Disorder, Chronic Obstructive; Chronic Heart Failure
• Interventions: Other: sip feeding with stable isotope infusion

• Registration Number: NCT02065141
• Lead Sponsor: Texas A&M University

Brief Summary

The aim of the present study is to validate a new method in healthy volunteers and those diagnosed with COPD and CHF that is able to measure protein digestion and absorption simultaneously. This method is used to quantify digestion and absorption in patients who are suspect of impaired digestion and absorption resulting in loss of nutrients.Findings may be used to develop treatment strategies to improve protein digestion and absorption in these patient groups.

Detailed Description

The study involves 1 screening visit of approximately 1-2 hours and 1 test day of approximately 8 hours. On the study day protein digestion and absorption will be measured using a mixture of amino acids that are made slightly heavier than normal, called stable isotopes. Subjects will receive feeding by sips to monitor changes in digestion and absorption, which can be picked up by stable isotope technology.

Study Timeline

• Study First Submitted: 2013-11-26
• Study First Submitted QC: 2014-02-14
• Study First Posted: 2014-02-17
• Study Start: 2014-11
• Primary Completion: 2019-01-19
• Study Completion: 2019-01-19
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-03
• Last Update Posted: 2022-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy	sip feeding with stable isotope infusion	screening visit: body weight and composition by DXA, height, and vital signs will be assessed. study day: stable isotope infusions with blood draws, sip feed
Chronic Heart Failure	sip feeding with stable isotope infusion	screening visit: body weight and composition by DXA, height, and vital signs will be assessed. Subjects may sign a medical release form to obtain medical information about them that will help determine study eligibility or can be used for later coding. study day: stable isotope infusions with blood draws, sip feed
Chronic Obstructive Pulmonary Disorder	sip feeding with stable isotope infusion	screening visit: body weight and composition by DXA, height, and vital signs will be assessed. Subjects may sign a medical release form to obtain medical information about them that will help determine study eligibility or can be used for later coding. study day: stable isotope infusions with blood draws, sip feed

Primary Outcome Measures

Name	Time	Method
protein metabolism in gut	In postabsorptive and prandial state every 20 minutes up to 8 hours before each sip feeding on study day	Digestion of the stable tracers of amino acid measured by plasma samples

Secondary Outcome Measures

Name	Time	Method
Body Composition	on screening or study day 1	Body composition as measured by Dual-Energy X-ray Absorptiometry
Respiratory muscle strength	on study day 1	determined by measurement of maximum breathing pressures
Skeletal muscle strength of hand	30 minutes on screening or study day	measurement of handrip strenth
Skeletal muscle strength of leg	30 minutes on screening or study day	measurement of muscle strength of leg using kin-com machine

Trial Locations

Locations (1)

Texas A&M University; 🇺🇸 College Station, Texas, United States